In cases of heart disease, such as one which requires decompression of one of the chambers of the heart, e.g. the left atrium or right atrium, a septal defect or shunt is created in the septum/wall between the two heart chambers to allow for the flow of blood from the high-pressure chamber to the low-pressure chamber, thus decompressing the high pressure chamber. Most of these procedures are performed surgically or by using non-removable metal stem-like devices.
Prior art devices for creating shunts often comprise a piercing tip which can be hazardous and cause injury to adjacent organs. Additionally, most of the prior art techniques create the shunt instantaneously, causing sudden increase in pressure and work-load on a portion of the heart which could result in acute heart failure. Also, most prior art devices are permanently implanted, creating the need for long-term antiplatelet and anti-coagulant medication to prevent clot formation. These medications increase the risk of life-threatening conditions such as bleeding or stroke.
Hence, what is needed is an efficient and small shunt device which may be delivered with ease within a human body for slowly creating a shunt over a period of time, resulting in a slow decompression of the high-pressure system and in turn, a slow increase in pressure and work-load in the low-pressure system. What is also needed is a shunt device which can be removed safely after the shunt is formed, obviating the need for long-term anticoagulant or antiplatelet medications. Further, there is need for a shunt device which exerts a sufficiently high compressive force on an organ wall to create a shunt, yet retains a small enough profile to be delivered through a minimally invasive delivery device, such as a catheter. There is also a need for a shunt device that does not rely solely on magnetic forces for correct orientation and positioning inside the human body.
Prior art devices for controlling valve function, specifically preventing the back-flow or leakage of fluid, create a fixed restriction which impedes the forward flow as well as restricting the backward flow, thereby increasing the pressure on the heart, and in turn, increasing the work-load.
Hence, what is also needed is an efficient and small device which may be delivered with ease within a human body and which dynamically controls the flow of fluid across a valvular structure. What is also needed is a device that controls the flow of fluid in one direction preferentially over the opposite direction, thereby augmenting or restoring the normal valvular function of a valve. What is also needed is a valve control device which can be removed safely.